BCG VACCINE Powder and solvent for suspension for injection Ref.[27960] Active ingredients: BCG vaccine

Posology

Adults and children aged 12 months and over

A dose of 0.1 ml of the reconstituted vaccine is injected strictly by the intradermal route.

Infants under 12 months of age

A dose of 0.05 ml of the reconstituted vaccine is injected strictly by the intradermal route.

National recommendations should be consulted regarding the need for tuberculin testing prior to administration of BCG Vaccine AJV.

Method of Administration

The injection site should be clean and dry. If antiseptics (such as alcohol) are applied to swab the skin, they should be allowed to evaporate completely before the injection is made.

BCG Vaccine AJV should be administered by personnel trained in the intradermal technique.

The vaccine should be injected strictly intradermally in the arm, over the distal insertion of the deltoid muscle onto the humerus (approx. one third down the upper arm), as follows:

The skin is stretched between thumb and forefinger.

The needle should be almost parallel with the skin surface and slowly inserted (bevel upwards), approximately 2 mm into the superficial layers of the dermis.

The needle should be visible through the epidermis during insertion.

The injection is given slowly.

A raised, blanched bleb is a sign of correct injection.

The injection site is best left uncovered to facilitate healing.

For information on the expected reaction following successful vaccination with BCG Vaccine AJV, see section 4.8.

BCG Vaccine AJV should be administered with a syringe of 1 ml subgraduated into hundredths of ml (1/100 ml) fitted with a short bevel needle (25G/0.50 mm or 26G/0.45 mm). Jet injectors or multiple puncture devices should not be used to administer the vaccine.

For instructions on reconstitution of the vaccine before administration, see section 6.6.

Overdose increases the risk of suppurative lymphadenitis and may lead to excessive scar formation.

Gross overdosage increases the risk of undesirable BCG complications.

For treatment of disseminated infections with BCG, refer to section 4.8.

2 years.

From a microbiological point of view the product should be used immediately after reconstitution. In use stability in terms of viability has been demonstrated for 4 hours after reconstitution.

Store in a refrigerator (2°C-8°C).

Do not freeze. Store in original package in order to protect from light.

For storage conditions after reconstitution of the vaccine, see section 6.3.

Powder in amber Type I glass vial with bromobutyl stopper and aluminium cap; 1 ml of solvent in Type I glass vial with a chlorobutyl stopper and an aluminium cap.

Packages of 1, 5, 10 vials and a 1 vial presentation including 1 unidose injection kit (one polypropylene syringe and two injection needles (one long for adding solvent and one short for intradermal injection)).

One vial of reconstituted vaccine contains 1 ml, corresponding to 10 doses for adults and children aged 12 months and over (0.1 ml) or 20 doses for infants under 12 months of age (0.05 ml).

Not all pack sizes may be marketed.

Reconstitution

Only solvent provided with the BCG Vaccine AJV should be used for reconstitution.

The rubber stopper must not be wiped with any antiseptic or detergent. If alcohol is used to swab the rubber stopper of the vial, it must be allowed to evaporate before the stopper is penetrated with the syringe needle.

The vaccine should be visually inspected both before and after reconstitution for any foreign particulate matter prior to the administration.

Using a syringe fitted with a long needle, transfer to the vial the volume of solvent given on the label. Carefully invert the vial a few times to resuspend the lyophilised BCG completely. DO NOT SHAKE. Gently swirl the vial of resuspended vaccine before drawing up each subsequent dose. When drawn up into the syringe the vaccine suspension should appear homogeneous, slightly opaque and colourless.

From a microbiological point of view the product should be used immediately after reconstitution. In use stability in terms of viability has been demonstrated for 4 hours after reconstitution.

Any unused vaccine or waste material should be disposed of in accordance with local requirements.